Caries,Dental, Caries; Initial, Occlusal Caries
Conditions
Keywords
early caries lesions, sealants, erupting molars
Brief summary
Sealants effectively arrest non-cavitated caries lesions on the fully erupted occlusal surface of permanent teeth. However, the clinical effectiveness of sealants is uncertain in preventing occlusal caries lesions in partially erupted permanent molars. This study aims to evaluate the progression of caries, the degree of retention, survival rate, and quality of the remnant after applying conventional total-etch resinous sealant and self-etch sealant in erupting molars.
Interventions
DRUGFluoride varnish
Thirty-eight permanent molars will receive 5% sodium fluoride varnish application every three months
DRUGConventional etch and rinse sealant
Thirty-eight permanent molars will receive conventional etch and rinse sealant
DRUGSelf-etch sealant
Thirty-eight permanent molars will receive self-etch sealant
Sponsors
Hue University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding of examiners is impossible to be done during intervention and follow up due to different natures of the materials. However, participants and outcome assessors could be blinded (double blinding).
Intervention model description
This is a 3 arm clinical trial. All selected permanent molars will be randomly equally allocated into three groups according to material used.
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
For children: 1. Children presenting with good general health and cooperative behavior. 2. Children having early caries lesions in a permanent molar (first or second). 3. Parents signed informed consent. For permanent molars: 1. Early caries lesions on the occlusal surface corresponding to International Caries Detection and Assessment System (ICDAS) scores 1 and 2. \[Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8\]. 2. Erupting molars: eruption stages 2 (fully erupted occlusal surface with less than half of the crown exposed) and 3 (fully erupted occlusal surface with more than half of the crown exposed). \[Carvalho JC, Ekstrand KR, Thylstrup A. Dental plaque and caries on occlusal surfaces of first permanent molars in relation to stage of eruption. J Dent Res. 1989 May;68(5):773-9\].
Exclusion criteria
For children: 1. Any allergy reported by the parents. 2. Children unable to return for recall visits. For permanent molars: 1. Teeth with occlusal surfaces completely covered by the gingival tissue. 2. Teeth with hypoplastic defects, restorations, or sealants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of new caries lesion | 3 months | ICDAS was considered "0'' for fully sealed teeth. A score of ICDAS≥1 was considered as new caries lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sealants retention | 3 months | Sealant retention was assessed as follows: total retention of sealant on the occlusal surface or the partial or complete absence of the sealant on the occlusal surface. |
| Quality of sealants | 3 months | Quality of the remnant United States Public Health Service criteria (USPHS): anatomical shape, marginal adaptation, surface texture, and marginal discoloration. |
Countries
Vietnam
Contacts
PRINCIPAL_INVESTIGATORVan Nhat Thang Le, DDS, PhD
Hue University of Medicine and Pharmacy
Outcome results
None listed